Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-05 @ 5:42 AM
Study NCT ID:
NCT02543918
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2015-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549079', 'term': 'ixekizumab'}, {'id': 'C505143', 'term': 'Boostrix'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '(800) 545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All randomized participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Ixekizumab + Boostrix® + Pneumovax®23', 'description': 'Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.', 'otherNumAtRisk': 41, 'otherNumAffected': 1, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Boostrix® + Pneumovax®23', 'description': 'Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixekizumab + Boostrix® + Pneumovax®23', 'description': 'Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.'}, {'id': 'OG001', 'title': 'Boostrix® + Pneumovax®23', 'description': 'Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.'}], 'classes': [{'title': 'Tetanus Vaccine Responders', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '51.2', 'groupId': 'OG001'}]}]}, {'title': 'Pneumococcal Vaccine Responders', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '90.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.4', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '19.2', 'groupDescription': 'Tetanus vaccine responders', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '11.0', 'groupDescription': 'Pneumococcal vaccine responders', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of \\>=1.0 (International Unit (IU) and a \\>=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is \\<=1.0 at baseline OR a \\>=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is \\> 1.0 IU at baseline.\n\nResponder to the pneumococcal vaccine is defined as a \\>=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against \\>50% of the 23 serotypes.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixekizumab + Boostrix® + Pneumovax®23', 'description': 'Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.\n\nBoostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.'}, {'id': 'FG001', 'title': 'Boostrix® + Pneumovax®23', 'description': 'Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixekizumab + Boostrix® + Pneumovax®23', 'description': 'Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.'}, {'id': 'BG001', 'title': 'Boostrix® + Pneumovax®23', 'description': 'Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '39.5', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '41.4', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2015-09-04', 'resultsFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-09', 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations', 'timeFrame': 'Week 6', 'description': 'Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of \\>=1.0 (International Unit (IU) and a \\>=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is \\<=1.0 at baseline OR a \\>=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is \\> 1.0 IU at baseline.\n\nResponder to the pneumococcal vaccine is defined as a \\>=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against \\>50% of the 23 serotypes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29116597', 'type': 'DERIVED', 'citation': 'Gomez EV, Bishop JL, Jackson K, Muram TM, Phillips D. Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants. BioDrugs. 2017 Dec;31(6):545-554. doi: 10.1007/s40259-017-0249-y.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females without compromised immune system\n* Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)\n\nExclusion Criteria:\n\n* Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists\n* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed\n* Have known allergy or hypersensitivity to any biologic therapy\n* Past vaccination allergy or Arthus-type hypersensitivity\n* Received a tetanus toxoid-containing vaccine within the last 5 years\n* Severe allergic reaction to Boostrix\n* Allergic to latex\n* Have been immunized with pneumococcal vaccine\n* Known hypogammaglobulinemia\n* History of Guillain-Barre Syndrome\n* Active infectious disease\n* Had a live vaccination within 1 year prior to screening, or intend to have a live vaccination during the course of the study\n* Evidence of a significant uncontrolled neuropsychiatric disorder -\n* Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self Report (16 Items) at screening\n* Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B\n* Had symptomatic herpes zoster within 3 months of screening\n* Women who are lactating'}, 'identificationModule': {'nctId': 'NCT02543918', 'briefTitle': 'A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Vaccination Response Following Administration of Ixekizumab to Healthy Subjects', 'orgStudyIdInfo': {'id': '16202'}, 'secondaryIdInfos': [{'id': 'I1F-MC-RHCA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixekizumab + Boostrix® + Pneumovax®23', 'description': 'Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.\n\nBoostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.', 'interventionNames': ['Drug: Ixekizumab', 'Drug: Boostrix®', 'Drug: Pneumovax®23']}, {'type': 'OTHER', 'label': 'Boostrix® + Pneumovax®23', 'description': 'Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.', 'interventionNames': ['Drug: Boostrix®', 'Drug: Pneumovax®23']}], 'interventions': [{'name': 'Ixekizumab', 'type': 'DRUG', 'otherNames': ['LY2439821'], 'description': 'Administered by SQ injection', 'armGroupLabels': ['Ixekizumab + Boostrix® + Pneumovax®23']}, {'name': 'Boostrix®', 'type': 'DRUG', 'otherNames': ['Tetanus, diphtheria, acellular pertussis vaccine (Tdap)'], 'description': 'Administered by IM injection', 'armGroupLabels': ['Boostrix® + Pneumovax®23', 'Ixekizumab + Boostrix® + Pneumovax®23']}, {'name': 'Pneumovax®23', 'type': 'DRUG', 'otherNames': ['Pneumococcal polysaccharide vaccine'], 'description': 'Administered by IM injection', 'armGroupLabels': ['Boostrix® + Pneumovax®23', 'Ixekizumab + Boostrix® + Pneumovax®23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}